CLINIC DESIGN
IMPULSE KL SERIES
INSTRUCTIONS FOR USE
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Dear Customers,
By purchasing a clinical bed from Malsch care & clinic design®
you have obtained a long-lasting medical device with functions
that meet all the requirements of everyday care while maintaining the highest standards of safety.
We would like to thank you for the trust you have placed in us.
Our company guarantees carefully selected materials and
continuous quality control while employing state-of-the-art
production technologies.
Complying with the usage and operating instructions helps to
prevent the risk of accidents and preserves the high value of
your clinical bed.
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CONTENTS
Specific function 7
Environmental Sustainability 7
Note regarding the
instructions for use 8
Pictograms / Symbols 8
Safety instructions 9
Technical Data 12
Rating Plate 13
Symbols on the patient’s hand controller 14
Symbols on the nurse’s control panel 15
Product designation 16
Functional representation 17
Description of function 18
Back rest 18
Mechanical release of the
Back rest (CPR) 18
Upper leg section 18
Height adjustment 18
Transfer position 19
Low position/
Fall prevention 19
Comfort sitting position 19
Auto contour 19
Trendelenburg-/
Anti-Trendelenburg position 20
Hand controller locking function 20
Braking and moving 21
Side rail (SR) adjustment 22
Integrated lying surface extension 23
Removable head / foot boards 24
Delivery and assembly 25
Accessories (optional) 26
Trapeze bar 26
Intravenous drip holder 26
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Bed light 26
Hand controller holder 27
Horizontal hand controller 27
Mattresses 27
Side rail heightening 27
Urine bottle / bag / basket 28
5th wheel 28
Trouble shooting 30
Product safety 31
Cleaning and disinfection 32
Maintenance 33
Storage 33
Warranty and service 34
Declaration of conformity 34
Certificates 35
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Room representation
Impulse 300 KL / Impulse 400 KL
SPECIFIC FUNCTION
ENVIRONMENTAL SUSTAINABILITY
Betten Malsch GmbH clinical beds are used in hospitals and
care areas. These beds are designed exclusively for this purpose. The comfort and functionality of the clinical beds make
life easier for staff as they carry out the tasks involved in patient care, and they aid compensation positioning and relief of
disabilities for treated patients in hospitals and care facilities.
If the clinical beds are used for other applications, then
prior written agreement from Betten Malsch GmbH is
required.
The product should be used as a working appliance and care
aid, and is subject to the insurance association’s regulations.
With regard to industry standards and regulations, the clinical
bed is a medical device. Therefore, this product should only be
used under medical supervision.
The clinical beds described in this instruction manual are
intended for adult patients with a body weight of at least
40 kg and a height of at least 146 cm. In accordance
with standard IEC 60601-2-52:2009/AMD1:2015, the
beds must not be used by patients whose body weight
and height do not meet these limits, or who have a BMI
under 17, as the risk of injury is significantly increased
for this group.
Caution! The use of incompatible side rails and
mattresses can lead to injury as body parts may
become trapped.
Betten Malsch GmbH clinical beds are manufactured in accordance with the relevant regulations, and in line with state
of the art process technologies, and are free from hazardous
materials. The materials used to finish surfaces are CFC and
solvent free.
Clinical beds that are removed from circulation due to age or
irreparable damage must be disposed of in accordance with
disposal regulations.
Caution ! When disposing of metal, wood and
electrical waste, please observe the relevant
local regulations.
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NOTE REGARDING THE INSTRUCTIONS FOR USE
PICTOGRAMS / SYMBOLS
The following instructions and guidelines in this manual are for
the nursing staff or other persons and staff tasked with using
and working with the clinical bed.
The instruction manual must be available to
users at all times in order to avoid any errors
in operation and to guarantee fault free operation. The nursing staff must have complete
knowledge of, and receive training on operation before using clinical beds for the first time.
The instruction manual is the basis for this.
The instruction manual is designed to apply to the Impulse KL
clinical bed range. The images, graphics and text it contains
may differ from the delivered equipment.
The manufacturer offers technician training for
maintenance and servicing work on their clinical beds. A certificate obtained as part of this
training authorises the holder to carry out technical work independently on the beds.
To help easy orientation in this instruction manual, we sometimes use pictograms as follows:
Please note! Instructions labelled in this way must
be followed in order to avoid injury or damage!
Information! This pictogram identifies information
which relates to the current subject!
Observe the instructions for maintenance and
repair work! We can supply you with special service instructions for accessories or complex maintenance instructions. You will find these at www.
bettenmalsch.de in the Service area.
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SAFETY INSTRUCTIONS
1. The instruction manual should be read and followed before using the clinical bed.
2. Explanation of the terms used on the rating plate.
CE: Conformity marking in accordance with Medical
Devices Directive
IPX6: Protection of electrical equipment from water spray
“only use in dry areas”
Protection Rating Class II (double insulation, pro-
tective insulation)
The instructions on the rating plate must be observed..
3. In the event of any fault or failing which could endanger
any person, the bed must not be used.
4. Only fully-trained specialists should operate electrically
operated clinical beds.
5. Before using the bed for the first time, the operator
should satisfy himself that it is safe to use and in a good
condition.
6. To ensure the patient does not fall when getting into or
out of the bed, the castors should always be placed in
the brake position.
7. The bed can be moved into various positions. When doing so, you must take care to ensure no parts of the body
or other objects are located in the adjustment area.
be taken to ensure that the patient does not come into
contact with the side rails when adjusting the lying position, to avoid trapping any part of the body.
9. The side rails must be taken down every day to check
their function, and should not bear any load of over 75
kg vertically or over 50 kg horizontally.
10. When using the mechanical emergency lowering of the
back rest (CPR), this must always also be held firmly to
avoid any sudden lowering.
11. The functions of the hand controller can be locked or
released via nurse’s control panel or by using the key
switch on the backside of the hand controller. The operation of the locking function should be checked on the
hand controller. F p.14/p.15
12. The power systems used must be operated using a VDE
approved power source – 220 V, 50/60 Hz mains socket.
13. The mains connection lead is also protected by a mechanical strain relief. Care must also be taken to ensure
that there are no sharp edges, mechanical stresses or
pinch/shear points.
14. The design of the hand controller means it can be hung
on the bed in such a way that the buttons are not activated inadvertently between 2 objects. Care must be taken
to ensure that the hand controller is fully accessible and
not trapped between the side rail and bedside table.
8. Only nursing staff may adjust the side rails. Care should
15. When using the clinical bed in a patient’s room, safety
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distances between walls, window benches or other objects must be observed. Safety distances depend on the
design and model of the clinical bed and are based on
height adjustments and tilting motion. The minimum distance is 30 mm.
16. The following subjects and actions are considered to be
‘Improper Use’:
Unauthorised activation of the electrical functions
Use of the bed by children under 12 years old
Moving the bed by pulling the mains cable or side
rail
Simultaneous adjustment of the clinical bed by sev-
eral people
Activation of the functions by patients without prior
instruction
Pulling the mains cable to remove it from the elec-
tricity supply
Moving the bed on a sloping or insecure surface
It is important that the following safety instructions are observed to prevent the risk of danger or injury to both patient
and carer and also avoid any potential damage to the bed:
The mattress used must fulfill the applicable safety
standards
For safety reasons, the handle on the trapeze bar
should be replaced completely every 5 years.
Service and repairs on electrical components
should only be carried out using original replacement parts from the manufacturer and must be carried out by specially trained staff.
The clinical bed is not suitable for extended oper-
ation beyond the working cycle of 2 minutes. If the
mains adapter is overloaded or if it overheats, it will
shut off automatically. Further operation will then
only be possible after a cooling period of approx.
30 minutes. (Observe the drive manufacturer’s
notes on the rating plate!)
Obstruction any part of the bed mechanism must
be absolutely avoided, as this can lead to damage
or complete disabling of the drive mechanism due
to overheating.
Equally, the safe working load should not be ex-
ceeded.
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If an immobile patient remains in the same position
for a longer period without use of positioning aids,
this can lead to pressure sores. The manufacturer
of the clinical bed is not liable for this in any way.
Electrically powered clinical beds are medical
products and are subject to technical safety checks
in accordance with the Medical Devices Directive
and Medical Devices Operator Ordinance § 6.
These regular checks must be carried out at least
once a year. A visual and operational inspection
of functional and electrical safety in accordance
with VDE0751 must be carried out to ensure this.
p. 33 Maintenance
Furthermore, electrically operated clinical beds
are electrical appliances, the safety of which is
the responsibility of the employer. The supervisory
function of this obligation is the responsibility of the
Berufsgenossenschaft für Gesundheitsdienst und
Wohlfahrtspflege (Employers’ Liability Insurance
Association for Health Service and Welfare Work
- BGW) and the Gewerbeaufsichtsamt (Trade Supervisory Board). The regulations of the Employers’
Liability Insurance Association for Health Service
and Welfare Work apply (abbreviated to BGV, formerly VBG). In particular BGV A2 (formerly VBG)
“ Electrical Units and Equipment” applies, which
requires regular inspection of movable electrical
equipment with a guideline of 6 months but at least
once a year. These inspections may only be carried
out by an electrical specialist or someone with electrical training using a special measurement and
inspection device. Inspections in accordance with
BGV A2 within the technical safety checks for med-
ical products may be carried out be specialist staff
trained by the manufacturer as these BGV inspections are included in the technical safety checks.
Electrically operated clinical beds are active medi-
cal products and must be listed in an inventory per
site in accordance with the Medizinprodukte Betreiberverordnung (MedProd-BetrV) Medical Products
Operation Regulations. We recommend you also
document the proper implementation of the required technical safety checks in this inventory and
note the date of the next inspection. The required
notes on technical safety checks already carried out
should be appended to the inventory.
Proper execution and traceable documentation of
the technical checks, maintenance and commissioning work prescribed by the manufacturer, as
well as the technical safety checks are required in
order to preserve the warranty right of the purchaser. If the operator of a medical product does not
meet their obligations, then this may lead to a risk
of damage and accidents, for which the manufacturer is explicitly not liable.
Any maintenance work is to be carried out in ac-
cordance with VDE0751-1 and the subsequent
technical safety check is to be documented.
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TECHNICAL DATA
Dimensions:
Impulse 300 KL/400 KL 216 x 106 cm
Impulse XL KL 216 x 116 cm
incl. wall bumper
Lying surface (LF):
Impulse 300 KL/400 KL 200 x 90 cm
Impulse XL KL 200 x 100 cm
Height adjustment:
Impulse 400 KL approx. 27 bis 80 cm*
Impulse 300 KL/XL KL approx. 36 bis 86 cm*
Backrest adjustment: 71° reclining angle for backrest
12 cm mattress compensation
Low voltage drive system
(SMPS switching power supply)
Electrical connection: 240V≈50Hz
Output voltage: 35V= 2A
Over-current off: 7,5-11,5A
Over-voltage off: 45V=
Standby operation: max. 0,5 Watt
Protection: IPX6
Protection class: II (with moveable earth conductor)
Upper leg adjustment: 43°
Trendelenburg: 14°
Antitrendelenburg: 15°
Maximum load: 250 kg
Impulse 300 KL / 400 KL ( 185 kg patient weight
+ 20 kg mattress
+ 45 kg accessories )
Maximum load: 300 kg
Impulse XL KL ( 235 kg patient weight
+ 20 kg mattress
+ 45 kg accessories )
Weight:
Impulse 300 KL/400KL approx. 120 kg
Impulse XL KL approx. 160 kg
* measured from the lying surface frame
Lifting system force:
Impulse 300 KL/400 KL 2x3000N
Impulse XL KL 2x6000N
LF adjustment force:
Impulse 300 KL/400 KL 2x3000N
Impulse XL KL: 3x3000N
Motor running time: 2min / off18min
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RATING PLATE
Bet ten Mals ch GmbH | Ro hbergs traße 9 | D -36208 Wil deck-O bersu hl
Tel.: +49 (0)6626 / 915 100 | Fax: +49 (0)6626 / 915 116
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2
3
4
5
Clinical bed Impulse KL
S/N 0815 1234567
Input: 230-240 V ≈ 50/60 Hz max 2A
Output: 35 V = 2 A
Operation: max. 2min / 18min off
Protection class: IPX6
Typical illustration of a rating plate on an Impulse 300 KL clinical bed, standard design with mains connection
250 kg
185 kg
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12
N
2016
S
P
2
X
E
T
3
N
4
O
I
T
E
C
5
67
6
11
10
I
N
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8
8
7
The rating plate is located on the underside of the lying surface, at the head of the bed, on the right. To inspect the rating
plate, raise the head to the upper position.
1. Model id.
2. Serial number
3. Electrical voltage, frequency, power consumption
4. Operating time of the electrical adjustment: please observe this point to prevent over heating! For example, the
bed can only be continuously operated for max. 2 min.
within 18 min.
5. Protection of electrical equipment from water spray
“only use in dry areas” Protection Rating Class II
(double insulation, protective insulation)
6. Indicates the next technical check after delivery in accordance with VDE0751-1
7. Explanation of the terms used on the rating plate:
Application part type B
Directive 2002/96/EC relating to old electrical
and electronic equipment
Conformity marking in accordance with Medical
Devices Directive
Protection Rating Class II (double insulation,
protective insulation)
“Only use in dry areas”
“Follow the instructions”
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SYMBOLS ON THE PATIENT’S HAND CONTROLLER
Blocking function
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S1
Back rest
adjustment
up
S3
Leg rest
adjustment
up
S5
Auto contour
up
S7
Lift adjustment
up
S9
Low
positioning
1
S2
Back rest
adjustment
down
S4
Leg rest
adjustment
down
S6
Auto contour
down
S8
Lift adjustment
down /
Transfer pos.
1
S10
Comfort
seating
1
only with Impulse 400 KL
R1
BLOCKED
No functions
operational
R2
FREE
All functions
available
R3
FREE
All functions
available
R4
FREE
All functions
available
SYMBOLS ON THE NURSE’S CONTROL PANEL
S1 S2
S3
S9
S15
S1 CPR (electric)
S2 Shock position
S9 Back rest adjustment up
S10 Leg rest adjustment up
S11 Auto contour up
S12 Lift adjustment up
S13 Anti-Trendelenburg position
S15 Back rest adjustment down
S16 Leg rest adjustment down
S17 Auto contour down
S18 Lift adjustment down
S19 Trendelenburg position
S4
S10
S16
ADJUSTMENTS
S5
S11
S17
S6
S12
S18
S7 S8
S13 S14
S19
BLOCKING FUNCTIONS
S3 Back rest adjustment block
S4 Leg rest adjustment block
S5 Auto contour block
S6 Lift adjustment block
S7 Trend /Anti-Trend block
S8 Locking of the hand controller (LED red = locked)
S14 Switch on the control panel (LED green = ON)
LED green = AC 220 Volt
Yellow LED indicates the battery is charging
(LED red =
locked)
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PRODUCT DESIGNATION
16 |
Impulse 300 KL (optional equipment)
Impulse XL KL
Impulse 400 KL
FUNCTIONAL REPRESENTATION
Adjustable
back rest
Seat section
(fixed)
Bed panel
Nurse’s
control panel
Telescopic
bed linen storage
Integrated bed extender
Foot pedal with central
brake (6) and fixed
direction (5) of the
double castors
Mount for IV holder
and accessories
Adjustable
lower leg rest
Telescopic
side rail extension
Adjustable
upper leg rest
CPR
emergency
lowering
Trapeze bar mount on
the back of the frame
and inside on both
left/right
Bed fronts release
mechanism
Adjustable
side rails
5th wheel
(optional)
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DESCRIPTION OF FUNCTION
Depending on the design and type of clinical bed, the bed can
be put into the following positions by adjusting the back rest,
the upper leg and the lower leg sections as well as the height
of the bed:
Back rest
Use the corresponding button on the hand controller to adjust
the back rest.
(Back rest button)
The back rest has a range of movement equivalent to a length
compensation to the head section of the bed of 120 mm.
This function (mattress compensation) allows the patient to sit
in a comfortable position without compressing or restricting the
stomach or upper body.
Mechanical release of the Back rest (CPR)
When using mechanical release of the back rest, hold it firmly
in the position engaged and take some weight off it if possible.
Then pull the release mechanism until the back rest goes down
noticeably. Slowly allow the back rest to fall back into its final
position.
Engaging the release mechanism:
Press the appropriate button (S2) on the hand controller; the
back rest drive is ready for use in every position after travelling
a short distance.
Upper leg section
Use the corresponding button on the hand controller to adjust
the upper leg section.
((Upper leg section operating button))
For safety reasons, this position should only be adjusted by
medical personnel.
The lower leg section can be put into a horizontal position by
nursing staff using a fine adjustment device. (stretched leg high
positioning)
Height adjustment
Use the corresponding button on the hand controller to adjust
the height.
(Height adjustment operating button)
Caution ! Please consider patient safety when
adjusting height! No other objects should be in
the area of the lifting mechanism.
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Transfer position
(only with Impulse 400 KL)
The tranfer position allows an optimum positional mounting
and dismounting in the seat area of the bed at sitting height.
Comfort sitting position
Use the corresponding button on the hand controller to set the
comfort sitting position.
Use the corresponding button on the hand controller and hold
it until the position is reached.
(Transfer position operating button)
Low position/Fall prevention
(Only with Impulse 400 KL)
Use the corresponding button on the hand controller to adjust
the low position.
(Low position operating button)
By actuating the Button the bed moves out of the transfer position to the low position.
Caution ! Before activating the button, you
must ensure that the lowered, splitted side rails
are retracted (F p. 22, Fig. 1) and that there
is nothing under the bed!
(Comfort sitting position operating button)
When the button is activated the adjustment motors on the
lying surface and the lifting mechanism operate simultaneously
to bring the bed into a sitting position.
This function should only be used with mobile patients and
patients without any physical complaints.
Caution ! Please consider patient safety when
setting the comfort sitting position! No other objects should be in the area of the lifting
mechanism.
Auto contour
Use the corresponding button on the hand controller to set
auto contour.
(Auto contour operating button)
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When this button is activated, the back and upper leg sections
are adjusted equally, so that the patient can be brought into an
upright sitting position.
This function should only be used with mobile patients and
patients without any physical complaints.
This function must only be used by specialist
staff and must be locked by specialist staff on
the back of the hand controller. Faulty settings
can lead to serious injury to the patient.
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Caution ! Please consider patient safety when
setting auto contour! No other objects should
be in the area of the lifting mechanism.
Trendelenburg-/ Anti-Trendelenburg position
The Impulse clinical bed range comes with lying surface inclination as standard.
The head or foot height is set using the button on the nurse’s
operating panel.
Caution ! Please consider patient safety when
adjusting bed inclination! No other objects
should be in the area of the lifting mechanism.
(Trendelenburg / Anti-Trendelenburg
operating button)
Hand controller locking function
The electrical unit combines state of the art technology and
first fault safety.
The locking function acts as one more safety precaution. The
locking function is located on the back of the hand controller
and is used by staff with a key switch. In the event of a failure
of the electrical motor, the functions can be disabled via the
corresponding rotary switch.
Operation:
The hand controller functions can be limited by turning the key
switch in the different switch positions. The symbols are clearly
described on p.14 of the instruction manual.
Operating the locking function is described in more detail on
p.14 (Hand controller symbols).
Further locking functions can be found on the nurse’s control
panel (F Diagram p.15)
Braking and moving
Impulse 300 KL / 400 KL / XL KL
The Impulse 300 KL / 400 KL / XL KL
model (movable at any height) has
a central castor locking mechanism
which is operated mechanically by
means of a central foot pedal. The
foot pedal is located in the middle of
the foot area of the moving frame.
The Impulse 300 KL / 400 KL / XL KL model has 3 different possible settings:
1. Central locking of the castors (foot pedal down)
2. 4 castors released 360° (foot pedal in the middle)
3. 1 castor fixed direction (foot pedal up)
Caution ! The clinical bed Impulse 300 KL /
400 KL / XL KL can be moved regardless of the
height of the lying surface. This should only be
carried out as an exception, and under the supervision of nursing staff. You must then check
that the castors are locked and ensure the bed
is in the braked position after moving. Take
care to ensure patient safety!
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Side rail (SR) adjustment
1. In the down position, the side rails are located on the
sides of the lying surface which helps stop the mattress
from slipping. (Fig. 1)
2. You can move the side rails to a mid-height position with
a tilting action to raise the side protection. This position
is particularly suitable as a mobility support when moving
the patient.
3. For height adjustment and for maximum height,
the side rail is locked in place by two push buttons
in the inside of the upper section. Use two hands
at the same time to carry out the telescopic adjustment up or down, and avoid any twisting. (Fig. 2)
Do not use force!
4. To lower the telescopic side rail, use the same process
as for raising.
5. To move the side rails back into the down position, press
the catches marked on the lower side rail bar in at the
same time, and tilt. (Fig. 3)
Caution ! When positioning the side protection
and raising the side rails, please ensure the
catches lock in properly, and check this. Always
use both hands to adjust the side rails!
Caution ! Activate the low position (Impulse
400 KL) only with the telescopic side rail retracted (Fig. 1)
Fig. 1
Fig. 2
Fig. 3
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1.
Integrated lying surface extension
(only Impulse 300 KL / 400 KL)
The clinical beds Impulse 300 KL/400 KL have an integrated
lying surface extension, which allows the lying surface to be
extended by 10/20 cm without requiring tools.
This is activated without use of any tools by means of two levers on the bottom of the foot end of the lying surface in three
simple steps:
1. Operate both levers simultaneously and while doing so
pull them towards you.
2.
3.
2. Pull the bed extension out fully and position the mattress
insert.
3. Now push the bed extension back in without using the
pedal until you hear it lock.
An intermediate position is possible with the 10 cm extension, which does not require an insert. Adjust the
mattress accordingly for this. Also, when using this position, take care to ensure that the lying surface is definitely locked in place.
Caution ! A mattress extension must be attached if the lying surface is extended to 20 cm.
Caution ! The lying surface extension should
only be activated by authorised specialist staff.
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Removable head / foot boards
Impulse KL clinical beds have head / foot boards that can be
removed without use of any tools as standard. These can be
released and removed from above using the quick connector
on the bed frame mounting (green lever).
Caution ! Ensure that the head / foot boards
are locked before using the bed.
Caution ! Secure the patient before removing
the head / foot boards.
Caution ! When sliding in the head / foot
boards, take care that no body parts or other
objects are in the dangerous area.
2.
1.
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DELIVERY AND ASSEMBLY
Betten Malsch GmbH clinical beds are generally delivered fully
assembled, or assembled by company technicians or authorised personnel on site.
The delivery should be checked for completeness and conformity.
Any defects or damage should be pointed out to the freight
company immediately, and noted on the delivery document.
Signing of the delivery documents by both parties is obligatory
before commissioning.
If necessary, e.g. for maintenance, simple assembly procedures
can also be performed by professional authorised persons.
We offer comprehensive service instructions
for expert, authorised staff for the assembly of
head / foot boards / lying surfaces as well as
the installation/replacement of lying surface
motors.
After completion of service and maintenance
work, the functionality of electrical units must
be checked.
Assembly bed front / lying surface
- The head / foot boards are removed without tools -
push fit fitting
- Replace the side rail and lying surface covers using appropriate fitting aids - perform a function test!
Replacing the drive mechanism
- Disconnect the power supply and remove the push fit
fittings
- Reconnect the push fit fittings of the individual units after
replacing the drive.
The manufacturer offers technician training for
maintenance and servicing work on their clinical
beds. A certificate obtained as part of this training authorises the holder to carry out technical
work independently on the beds.
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ACCESSORIES (OPTIONAL)
Trapeze bar
The trapeze bar can be inserted either left or right of the
head end in the designated mounting sockets on the lying surface frame. An additional mounting socket can be
found on the wall bumper at the head end. Please ensure
the bolts sit properly in the intended notch in the mounting.
The safe working weight is 75 kg. .
Intravenous drip holder
The IV drip holder can be inserted into the designated mounting sockets in the lying surface frame either left or right of the
head/foot end.
The intravenous drip stand is only designed for hanging IV
drips, not for attaching other accessories or similar.
The maximum load is 8 kg (2 kg per hook)
Bed light
Like the IV drip holder, the bed light is fitted in the
mounting provided on the frame of the lying surface.
26 |
Caution ! For safety reasons, the bed light
should only be used with the clinical bed manufacturer’s original adapter, and fitted by authorised specialist staff.
You must follow the safety instructions in the
instruction manual for the bed light.
Hand controller holder
Mattresses
The additional hand controller
holder allows you to place the
hand control within reach of the
patient.
Caution ! The hand controller holder is flexible
and must not be used as an aid to standing up
or a handle.
Horizontal hand controller
The additionally available horizontal hand controller can also be
connected to the controls and allows the lying patient easy access
to the functions.
Caution ! The hand controller holder must not
be used as an aid to standing up or a handle.
Caution ! The additional hand controller must
only be connected by authorised specialist staff.
Betten Malsch GmbH offer a range of individually made special mattresses for the widest range of applications and demands on lying surface contours of clinical beds. Please ask
your specialist retailer of the manufacturer for the right mattress for your requirements.
Caution ! Only use mattresses tested and authorised by Betten Malsch GmbH.
For safety reasons a minimum protective height
of 220 mm should be maintained between the
upper edge of the mattress and the upper edge
of the side rail. This protective height is directly
related to the height of the mattress!
Side rail heightening
To protect from decubitus (pressure sores) and to accommodate patients with hip or spine injuries, you can use various
alternating pressure systems and underlays, which mean
the mattress is built up by more than 16 cm. For this, Betten
Malsch GmbH offer an extended height side rail elevation in
its range of accessories.
| 27
Caution ! Only use original bed accessories
from Betten Malsch GmbH. Side rail extensions
are aligned to and approved by the required
DIN standards and Betten Malsch clinical beds..
Caution ! Ensure that the foot pedal of the central brake is in the central position (castors rotate freely through 360°). Rotation is not possible with a fixed brake or fixed direction setting!
28 |
Urine bottle / bag / basket
The mounting for the urine bottle basket / bottle bag can be
found on the lying surface frame. The urine bottle basket /
urine bottle can be attached to both the left and right side of
the bed.
Caution ! Before you attach the additional
equipment, ensure that it will not lead to a collision with other bed parts or other equipment
within the room.
5th wheel
The centrally placed 5th wheel makes rotation of the bed easier during patient transport. It is locked using the foot pedal
located on the side and enables the bed to be turned easily
on its own axis.
Caution ! Ensure that there will not be a collision with fittings or furnishings or other objects
when turning the bed.
Caution ! It is essential that the fixed castor setting is released after rotation!
| 29
TROUBLE SHOOTING
Motors do not
operate via the
hand controller
Adjustments
using the electric motor are
not functioning
properly
Mains cable is
not plugged in
Socket not live Check socket
Cabling plug
connection not
sitting correctly
Hand controller
or motor is
faulty
Locking the
functions on
the hand controller
There is an
obstacle in the
adjustment
area
The safe working load has
been exceeded
Plug in the
mains cable
Check plug
connection
to motor and
hand controller
Inform the
operator, retailer or Betten
Malsch GmbH
Releasing
the functions
on the hand
controller
Check moving
parts and
remove any
foreign bodies
Reduce the
load
Motors cut out
after a longer period of operation
Opposite function
activates when
operating the
hand controller
buttons
The side rails can
no longer be set
up properly
Castors do not
brake or do not
roll
The adjustment
time or safe
working load has
been exceeded,
and the control
unit has reacted to
overheating
Motor plugs are
mixed up
The mechanism is
obstructed or bent
A foreign body
has got into the
rollers
The castor system
is faulty
Allow the motor
system to cool
down properly
Check the correct
cables or inform
your operator,
retailer or Betten
Malsch GmbH
Check all moving
parts and remove
any foreign bodies, or contact our
customer service
team
Remove foreign
bodies
Contact our
customer service
team
30 |
PRODUCT SAFETY
The product bears the CE marking and thus meets the requirements of German and European safety standards
applicable to that product.
Standard Comment
Medical device in accordance with 93/42/ EEC Medical Device Directive (CE marking)
MPG German Medical Products Law (MPG)
DIN EN ISO 9001 Quality management system
DIN EN ISO 14001 Environmental management system
DIN EN ISO 14971 Risk analysis
DIN EN 12182 Assistive products for persons with disability
DIN EN 60601-2-52 Medical electrical equipment
DIN EN 60601-1 Medical electrical equipment
DIN EN 60601-1-2 EMV – electromagnetic compatibility
DIN EN 12530 / DIN EN 12531 Medical castors
DIN EN ISO 15223-1 Symbols for identification of medical products
DIN EN 1041 Symbols and information accompanying a medical product
DIN 33402-1 Human body dimensions
DIN 68861-1 Furniture surfaces
BfArM recommendation BfArM (Federal Institute for Drugs and Medical Devices)
| 31
CLEANING AND DISINFECTION
Disinfection
The clinical bed should be disinfected regularly, and at least before every change of patient. All detergents in accordance with DIN
EN 12720 are suitable for wipe-down disinfection of the bed. The clinical bed should not be disinfected in inline washing systems.
Betten Malsch GmbH recommends the detergents Terralin, Perform and Sagrotan-Med or equivalent detergents for disinfection.
The detergents used for disinfection must only be used in accordance with the manufacturer’s instructions.
Caution! Under no circumstances use abrasives, cleaning pads or stainless steel cleaners for cleaning. Before
using any disinfectants, please consider the dosage and any potential hazards that may be caused by combining them with other substances. Remove the plug from the mains socket when disinfecting the clinical bed and
protect the drive mechanisms from moisture.
We provide separate instructions for cleaning and disinfecting our clinical beds.
32 |
MAINTENANCE
STORAGE
The manufacturer is only liable for the safety and reliability of
the product if it is maintained regularly and used in accordance with the safety instructions. If any significant faults are
found during maintenance work which mean the safe operation of the product cannot be guaranteed, the product should
be taken out of use. Maintenance work should be carried out
at least once a year.
The regulations within the general Operator Ordinance and
the regulations for use of electrically movable devices §6 MPBetreibV as well as the BGV A3 – electrical units – and equipment in accordance with BetrSichV, TRBS, DIN VDE 07010702 apply.
We offer inspection plans for servicing our clinical beds in a separate service guide!
Any faults which impair the function and
safety of the clinical bed must be resolved before the bed is used again and
must be reported to the relevant person.
Only original parts from Betten Malsch GmbH
should be used.
The following steps should be taken when storing clinical beds.
Pull out the mains plug and keep safe for trans-
port.
Supply the battery (optional) regularly with power
so that deep discharge does not occur.
Remove any accessories such as bed lamps,
trapeze bars, etc.
Cover the clinical bed so that the head/foot
boards and the frame cannot be damaged.
Mark the storage date clearly on the bed (due to
maintenance intervals)
Lock the hand controller
Caution! The same conditions apply to the storage of clinical beds as to the working environment (temperature, humidity, heat, etc.)
The manufacturer’s transport aid should be
used to transport the beds.
| 33
WARRANTY AND SERVICE
By purchasing a clinical bed from Betten Malsch GmbH, you
have chosen a premium, high-quality product.
The clinical beds have a 24-month warranty
beginning from the purchase date.
In the event of faults caused by materials or manufacture within
the warranty period, you will receive a replacement or have the
fault repaired free of charge. This excludes faults and errors
caused by inappropriate handling or external influences.
Our normal terms of business and delivery apply.
If you have any questions, please contact us
on the following numbers:
Customer Service
Phone: +49 (0)6626 / 915 128
Fax: +49 (0)6626 / 915 127
info@bettenmalsch.de
bettenmalsch.com
DECLARATION OF CONFORMITY
34 |
CERTIFICATES
CERTIFICATECERTIFICATE
CERTIFICATECERTIFICATE
CERTIFICATECERTIFICATE
Certicate registration No. 73 105 1297
Audit report No. 4310 8904
Management system as per
ISO 13485:2016
EN ISO 13485:2016+AC:2016
Evidence of conformity with the above standard(s) has been furnished
and is certied in accordance with TÜV PROFiCERT procedures for
Betten Malsch GmbH
Rohbergstraße 9
36208 Wildeck - Obersuhl / Germany
Development, manufacturing and distribution of
clinic- and health care bed systems, room furnishing
D-ZM-14137-01-01
This certication was conducted in accordance with the TÜV PROFiCERT auditing and certication procedures and is subject to
regular surveillance audits. Veriable under www.procert.com. Original certicates contain a glued on hologram.
TÜV Technische Überwachung Hessen GmbH, Robert-Bosch-Straße 16, D-64293 Darmstadt, Tel. +49 6151/600331 Rev-GB-1904
scope:
Certicate valid from 2019-04-01 to 2020-07-10
First certication 2017-07-11
Certication body of TÜV Hessen
PAGE 1 OF 1.
– Head of Certication body –
Darmstadt, 2019-04-01
Management system as per
DIN EN ISO 9001:2015
Evidence of conformity with the above standard(s) has been furnished
and is certied in accordance with TÜV PROFICERT procedures for
Betten Malsch GmbH
Rohbergstraße 9
36208 Wildeck - Obersuhl
Germany
scope:
Development, manufacturing and distribution of
clinic- and health care bed systems, room furnishing
D-ZM-14137-01-00
PAGE 1 OF 1.
Certicate valid from 2019-10-01 to 2022-09-30
First certication 2004-07-21
Certicate registration No. 73 100 1297
Audit report No. 4352 8721
This certication was conducted in accordance with the TÜV PROFiCERT auditing and certication procedures and is subject to
regular surveillance audits. Veriable under www.tuev-club.de. Original certicates contain a glued on hologram.
TÜV Technische Überwachung Hessen GmbH, Robert-Bosch-Straße 16, D-64293 Darmstadt, Tel. +49 6151/600331 Rev-GB-1711
Darmstadt, 2019-09-26
Certication body of TÜV Hessen
– Head of Certication body –
Management system as per
DIN EN ISO 14001:2015
Evidence of conformity with the above standard(s) has been furnished
and is certied in accordance with TÜV PROFICERT procedures for
Betten Malsch GmbH
Rohbergstraße 9
36208 Wildeck - Obersuhl
Germany
scope:
Development, manufacturing and distribution of
clinic- and health care bed systems, room furnishing
D-ZM-14137-01-00
PAGE 1 OF 1.
Certicate valid from 2019-10-01 to 2022-09-30
First certication 2013-10-01
Certicate registration No. 73 104 1297
Audit report No. 4352 8721
This certication was conducted in accordance with the TÜV PROFiCERT auditing and certication procedures and is subject to
regular surveillance audits. Veriable under www.tuev-club.de. Original certicates contain a glued on hologram.
TÜV Technische Überwachung Hessen GmbH, Robert-Bosch-Straße 16, D-64293 Darmstadt, Tel. +49 6151/600331 Rev-GB-1711
Darmstadt, 2019-09-26
Certication body of TÜV Hessen
– Head of Certication body –
| 35
Ar t.-No.: 91300 102101.4
EN, Edition 10/2019, Rev. 1.4
Colours may vary
Technical modifications reser ved
Betten Malsch GmbH | Rohbergstraße 9 | 36208 Wildeck-Obersuhl | GER MANY
Phone: +49 (0)6626 / 915 100 | Fax: +49 (0)6626 / 915 116
bettenmalsch.com | info@bettenmalsch.de
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